Re: Aseptic Experience

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Thank you for that information Timothy, I will be forwarding this to our
operations manager and let you know if they request anything else or if we
can move forward with the secondary screening/interview.

Cordially,

*Joyce Barreto*
Escalate Life Sciences
Administrative Assistant/Recruiter
Cell: (407) 987-7529
Office: (877) 213-7740
www.escalatesciences.com
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On Thu, Jan 29, 2026 at 1:30 AM TJ Bourdeau <tjphuhs@gmail.com> wrote:

> Joyce,
>
>
> Below is my response to your text sent on 01/28/26:
>
>
> At Formulated Solutions, I’ve supported GMP manufacturing operations for
> approximately 3+ years, with direct involvement in quality oversight of
> controlled environment and aseptic-adjacent manufacturing, including nasal
> spray production lines.
>
> My experience includes on-floor Quality support of manufacturing
> operations conducted in controlled environments where we required the
> dawning and doffing of “bunny suit” gowning, where I provided IPQA and FPQA
> oversight during active production runs. While I was not an aseptic
> operator, I was responsible for ensuring aseptic technique, procedural
> adherence, and documentation accuracy were maintained throughout
> manufacturing activities. This included line clearance verification, batch
> record review, real-time documentation support, and escalation of quality
> concerns during production.
>
> As I progressed into Quality Supervisor and then QA Manager roles, my
> responsibilities expanded to include review and approval of batch records
> associated with aseptic/controlled-environment steps, deviation
> investigations related to aseptic practices or documentation errors, and
> CAPA implementation to strengthen right-first-time execution. I also
> supported inspection readiness and participated in FDA and customer audit
> shadowing, including on-floor support and follow-up documentation.
>
> Overall, my aseptic manufacturing experience is rooted in quality
> governance and oversight of nasal spray manufacturing performed under
> GMP-controlled environments, with a strong focus on compliance,
> documentation integrity, and risk-based decision-making during live
> production.
>
>
>
> Let me know if you need anything else from me,
>
> TJ
>